Skip to main content
SpringerLink
Log in

Secukinumab: First Global Approval

  • R&D Insight Report
  • Published:
Drugs Aims and scope Submit manuscript

Abstract

Secukinumab (Cosentyx™) is a fully human monoclonal antibody against interleukin-17A, formulated for intravenous and subcutaneous administration. It received its first global approval in Japan on 26 December 2014 for the treatment of psoriasis and psoriatic arthritis in adults who are not adequately responding to systemic therapies (except for biologic agents). In the USA and the EU, secukinumab was approved in early 2015 for the treatment of patients with moderate-to-severe plaque psoriasis. Secukinumab is also being investigated in patients with ankylosing spondylitis and rheumatoid arthritis. This article summarizes the milestones in the development of secukinumab leading to its first approval for the treatment of adult patients with psoriasis and psoriatic arthritis.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Similar content being viewed by others

References

  1. Lønnberg AS, Zachariae C, Skov L. Targeting of interleukin-17 in the treatment of psoriasis. Clin Cosmet Investig Dermatol. 2014;7:251–9.

    Article  PubMed Central  PubMed  Google Scholar 

  2. Novartis Pharmaceuticals Corporation. Advisory Committee briefing materials: secukinumab (AIN457). 2014. http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/DermatologicandOphthalmicDrugsAdvisoryCommittee/UCM419023.pdf. Accessed 17 Dec 2014.

  3. Novartis International AG. First in the world regulatory approval of Novartis’ Cosentyx™ in Japan for both psoriasis and psoriatic arthritis [media release]. 26 Dec 2014. http://www.novartis.com/newsroom/media-releases/en/2014/1883568.shtml.

  4. European Commission. Commission implementing decision for Cosentyx™ (secukinumab). 15 Jan 2015. http://ec.europa.eu/health/documents/community…/dec_130444_en.pdf. Accessed 29 Jan 2015.

  5. US Food and Drug Administration. FDA approves new psoriasis drug Cosentyx [media release]. 21 Jan 2015. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm430969.htm.

  6. Gan EY, Chong WS, Tey HL. Therapeutic strategies in psoriasis patients with psoriatic arthritis: focus on new agents. BioDrugs. 2013;27(4):359–73.

    Article  CAS  PubMed  Google Scholar 

  7. Bruin G, Dragatin C, Aigner B, et al. The anti IL-17A IgG1 antibody distributes in dermal interstitial fluid as demonstrated by using dermal open flow microperfusion after a single 300 mg subcutaneous administration; assessment in healthy volunteers and patients with moderate-to-severe plaque psoriasis. J Invest Dermatol. 2014;134:S18.

    Article  Google Scholar 

  8. Chioato A, Noseda E, Stevens M, et al. Treatment with the interleukin-17A-blocking antibody secukinumab does not interfere with the efficacy of influenza and meningococcal vaccinations in healthy subjects: results of an open-label, parallel-group, randomized single-center study. Clin Vaccine Immunol. 2012;19(10):1597–602.

    Article  PubMed Central  CAS  PubMed  Google Scholar 

  9. Rich P, Sigurgeirsson B, Thaci D, et al. Secukinumab induction and maintenance therapy in moderate-to-severe plaque psoriasis: a randomized, double-blind, placebo-controlled, phase II regimen-finding study. Br J Dermatol. 2013;168:402–11.

    Article  CAS  PubMed  Google Scholar 

  10. Papp KA, Langley RG, Sigurgeirsson B, et al. Efficacy and safety of secukinumab in the treatment of moderate to severe plaque psoriasis: a randomised, double-blind, placebo-controlled phase II dose-ranging study. Br J Dermatol. 2012;168(2):412–21.

    Article  Google Scholar 

  11. Langley RG, Elewski BE, Lebwohl M, et al. Secukinumab in plaque psoriasis: results of two phase 3 trials. N Engl J Med. 2014;371(4):326–38.

    Article  PubMed  Google Scholar 

  12. Blauvelt A, Prinz JC, Gottlieb AB, et al. Secukinumab administration by pre-filled syringe: efficacy, safety, and usability results from a randomized controlled trial in psoriasis (FEATURE). Br J Dermatol. 2014. doi:10.1111/bjd.13348.

  13. Paul C, Lacour JP, Tedremets L, et al. Efficacy, safety and usability of secukinumab administration by autoinjector/pen in psoriasis: a randomized, controlled trial (JUNCTURE). J Eur Acad Dermatol Venereol. 2014. doi:10.1111/jdv.12751.

  14. Langley RGB, Feldman SR, Nyirady J, et al. The 5-point Investigator’s Global Assessment (IGA) scale: a modified tool for evaluating plaque psoriasis severity in clinical trials. J Dermatolog Treat. 2013. doi:10.3109/09546634.2013.865009.

  15. Langley RG, Reich K, Papavassilis C, et al. Multiple imputation methodology is reflective of secukinumab efficacy in real clinical practice: data from the FIXTURE and ERASUE studies in moderate to severe plaque psoriasis [abstract plus poster P99]. In: Psoriasis from Gene to Clinic 7th International Congress. 2014.

  16. Kingo K, Sofen H, Pathan R. Secukinumab prefilled syringes demonstrate patient satisfaction: analysis of the Self-Injection Assessment Questionnaire (SIAQ) in the FEATURE study [abstract no. P8137]. In: 72nd Annual Meeting of the American Academy of Dermatology. 2014.

  17. Kreutzer K, Lacour JP, You R. Secukinumab autoinjectors demonstrate patient satisfaction: an analysis of the Self-Injection Assessment Questionnaire (SIAQ) in the JUNCTURE Study [abstract no. P8417]. In: 72nd Annual Meeting of the American Academy of Dermatology. 2014.

  18. Blauvelt A, Gottlieb A, Sigurgeirsson B. Secukinumab efficacy in subjects with moderate-to-severe plaque psoriasis and concomitant psoriatic arthritis: a subanalysis of the ERASURE study [abstract no. P8033]. In: 72nd Annual Meeting of the American Academy of Dermatology. 2014.

  19. Gottlieb A, Langley R, Philipp S, et al. Improvement in psoriasis symptoms and physical functioning with secukinumab compared with placebo and etanercept in subjects with moderate-to-severe plaque psoriasis and psoriatic arthritis: results of a subanalysis from the phase 3 fixture study [abstract no. L7]. Arthritis Rheum. 2013;65(12):3322.

    Google Scholar 

  20. Papp K, Karpov A, Papavassilis C. Secukinumab efficacy in relationship with response to previous biologic psoriasis therapy: a subanalysis from the ERASURE Study [abstract no. P8011]. In: 72nd Annual Meeting of the American Academy of Dermatology. 2014.

  21. Rich P, Karpov A, Papavassilis C. Secukinumab efficacy stratified by body weight: a subanalysis from the ERASURE study [abstract no. P8013]. In: 72nd Annual Meeting of the American Academy of Dermatology. 2014.

  22. Warren R, Guettner A, Morita A, et al. Secukinumab efficacy in subjects with moderate to severe plaque psoriasis: pooled subgroup analyses by patient age of 4 phase 3 clinical studies [abstract no. P7563]. J Am Acad Dermatol. 2014;70(5 Suppl 1):AB186.

  23. Ohtsuki M, Morita A, Abe M, et al. Secukinumab efficacy and safety in Japanese patients with moderate-to-severe plaque psoriasis: subanalysis from ERASURE, a randomized, placebo-controlled, phase 3 study. J Dermatol. 2014;41(12):1039–46.

    Article  CAS  PubMed  Google Scholar 

  24. Thaci D, Humeniuk J, Frambach Y, et al. Secukinumab in moderate-to-severe plaque psoriasis: results from the Secukinumab Trial Analyzing the potential of intravenous administration To Upgrade the REsponse in psoriasis (STATURE) [abstract]. J German Soc Dermatol. 2014;12(Suppl):13.

    Google Scholar 

  25. Mrowietz U, Leonardi C, Girolomoni G, et al. Secukinumab ‘fixed-interval’ versus ‘retreatment-as-needed’ regimen for moderate-to-severe plaque psoriasis: results from the Study Comparing secukinumab Use in Long-term Psoriasis maintenance therapy: fixed regimen versus re-Treatment Upon start of Relapse (SCULPTURE) [abstract]. Aust J Dermatol. 2014;55(Suppl 1):42.

    Google Scholar 

  26. Mease P, McInnes IB, Kirkham B, et al. Secukinumab, a human anti-interleukin-17A monoclonal antibody, improves active psoriatic arthritis and inhibits radiographic progression: efficacy and safety data from a phase 3 randomized, multicenter, double-blind, placebo-controlled study [abstract no. 953]. Arthritis Rheum. 2014;66(Supp. 10):S423–S4.

  27. McInnes IB, Mease PJ, Kirkham B, et al. Secukinumab, a human anti-interleukin-17A monoclonal antibody, improves active psoriatic arthritis: 24-week efficacy and safety data from a phase 3 randomized, multicenter, double-blind, placebo-controlled study using subcutaneous dosing [abstract no. L1]. In: Annual Meeting of the American College of Rheumatology. 2014.

  28. Baeten D, Baraliakos X, Braun J, et al. Anti-interleukin-17A monoclonal antibody secukinumab in treatment of ankylosing spondylitis: a randomised, double-blind, placebo-controlled trial. Lancet. 2013;382(9906):1705–13.

    Article  CAS  PubMed  Google Scholar 

  29. Baeten DL, Braun J, Baraliakos X, et al. Secukinumab, a monoclonal antibody to interleukin-17A, significantly improves signs and symptoms of active ankylosing spondylitis: results of a 52-week phase 3 randomized placebo-controlled trial with intravenous loading and subcutaneous maintenance dosing. [abstract no. 819]. Arthritis Rheum. 2014;66(Suppl 10):S360.

    Google Scholar 

  30. Sieper J, Braun J, Baraliakos X, et al. Secukinumab, a monoclonal antibody to interleukin-17A, significantly improves signs and symptoms of active ankylosing spondylitis: results of a phase 3, randomized, placebo-controlled trial with subcutaneous loading and maintenance dosing. [abstract no. 536]. Arthritis Rheum. 2014;66(Supp. 10):S232.

  31. Genovese MC, Durez P, Richards HB, et al. Efficacy and safety of secukinumab in patients with rheumatoid arthritis: a phase II, dose-finding, double-blind, randomised, placebo controlled study. Ann Rheum Dis. 2012;72(6):863–9.

    Article  PubMed  Google Scholar 

  32. Durez P, Genovese MC, Richards HB, et al. Secukinumab treatment provides sustained response over one year in patients with rheumatoid arthritis [abstract no. O17]. Rheumatology. 2012;51(Suppl 3):329.

  33. Strand V, Kosinski M, Gnanasakthy A, et al. Secukinumab treatment in rheumatoid arthritis is associated with incremental benefit in the clinical outcomes and HRQoL improvements that exceed minimally important thresholds. Health Qual Life Outcomes. 2014. doi:10.1186/1477-7.

  34. Adami S, Beaulieu A, Rahman P, et al. A randomized placebo-controlled phase 2 study to evaluate efficacy, safety and tolerability of two secukinumab loading dose regimens in subjects with active rheumatoid arthritis despite treatment with methotrexate [abstract]. Arthritis Rheum. 2013;65(Suppl 10):S220.

    Google Scholar 

  35. Burmester GR, Durez P, Shestakova G, et al. Association of HLA-DRB1 alleles with clinical responses to the anti-interleukin-17A monoclonal antibody secukinumab in a cohort of patients with active rheumatoid arthritis: an exploratory phase 2 biomarker study [abstract no. 1737]. Arthritis Rheum. 2013;65(Suppl 10):1737.

    Google Scholar 

  36. Dick AD, Tugal-Tutkun I, Foster S, et al. Secukinumab in the treatment of noninfectious uveitis: results of three randomized, controlled clinical trials. Ophthalmology. 2013;120(4):777–87.

    Article  PubMed  Google Scholar 

  37. Havrdova E, Belova A, Goloborodko A, et al. Sensitivity analysis of a phase IIa study of secukinumab in relapsing remitting multiple sclerosis. Mult Scler. 2013;1:210–1.

    Google Scholar 

  38. Hueber W, Sands BE, Lewitzky S, et al. Secukinumab, a human anti-IL-17A monoclonal antibody, for moderate to severe Crohn’s disease: unexpected results of a randomised, double-blind placebo-controlled trial. Gut. 2012;61(12):1693–700.

    Article  CAS  PubMed  Google Scholar 

  39. Matteson EL, Dasgupta B, Schmidt WA, et al. A 2-week single-blind, randomized, 3-arm proof of concept study of the effects of secukinumab (anti-IL17 mAb), canakinumab (anti-IL-1b mAb), or corticosteroids on initial disease activity scores in patients with PMR, followed by an open-label extension to assess safety and effect duration [abstract no. 885]. Arthritis Rheum. 2014;66(Supp. 10):S391–S2.

  40. US National Institutes of Health. The effects of a single intravenous administration of secukinumab (AIN457) or canakinumab (ACZ885) in dry eye patients. 2012. https://clinicaltrials.gov/ct2/show/results/NCT01250171?sect=X70156. Accessed 15 Dec 2014.

  41. Philipp S, Escrig C, Papavassilis C, et al. Secukinumab treatment shows a neutral impact on the lipid profile of patients with moderate to severe plaque psoriasis in a dose-ranging study [abstract no. P6508]. In: 71st Annual Meeting of the American Academy of Dermatology. 2013.

  42. Tsai T, Blauvelt A, Karpov A, et al. Evaluation of infections with secukinumab in a pooled analysis of 10 clinical studies of moderate-to-severe plaque psoriasis [abstract no. 193]. J Invest Dermatol. 2014;134:S33.

    Article  Google Scholar 

  43. Reich K, Blauvelt A, Armstrong A, et al. Secukinumab, a novel anti-IL-17A antibody, exhibits low immunogenicity during long-term treatment in subjects with psoriasis [abstract plus poster P103]. In: Psoriasis from Gene to Clinic 7th International Congress. 2014.

  44. Novartis. Head-to-head psoriasis study demonstrates superiority of Novartis Cosentyx™ to Stelara® in clearing skin [media release]. 12 Dec 2014. http://www.novartis.com. Accessed 6 Jan 2015.

  45. Griffiths C, Guettner A, Prinz J, et al. Secukinumab safety in subjects with moderate to severe plaque psoriasis: a pooled analysis of neutropenia from 10 clinical studies [abstract no. P8266]. J Am Acad Dermatol. 2014;70(5 Suppl 1):AB188.

  46. Ward N, Guettner A, Sands B, et al. Secukinumab safety and tolerability in subjects with moderate to severe plaque psoriasis: a pooled subgroup analysis of 10 clinical studies evaluating exacerbation of Crohn’s disease [abstract no. P8233]. J Am Acad Dermatol. 2014;70(5 Suppl 1):AB188.

Download references

Disclosure

The preparation of this report was not supported by any external funding. During the peer review process the manufacturer of the agent under review was offered an opportunity to comment on the article. Changes resulting from any comments received were made by the author on the basis of scientific completeness and accuracy. M. Sanford and K. McKeage are salaried employees of Adis, Springer SBM.

Author information

Authors and Affiliations

  1. Springer, Private Bag 65901, Mairangi Bay, 0754, Auckland, New Zealand

    Mark Sanford & Kate McKeage

Authors
  1. Mark Sanford
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Kate McKeage
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Kate McKeage.

Additional information

This profile has been extracted and modified from the Adis R&D Insight drug pipeline database. Adis R&D Insight tracks drug development worldwide through the entire development process, from discovery, through pre-clinical and clinical studies to market launch.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Sanford, M., McKeage, K. Secukinumab: First Global Approval. Drugs 75, 329–338 (2015). https://doi.org/10.1007/s40265-015-0359-0

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s40265-015-0359-0

Keywords

Search

Navigation